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RedHill Biopharma Ltd. RDHL announced encouraging preliminary top-line data from the exploratory phase II study in the United States, evaluating its oral drug candidate, opaganib (Yeliva), as a potential treatment for patients hospitalized with COVID-19 pneumonia. Data from the study showed that the opaganib is safe and demonstrated greater improvement in reducing oxygen requirement by end of treatment at day 14.
Moreover, primary and secondary efficacy outcomes correlated with clinical improvement as defined by the World Health Organization (WHO) ordinal scale. Full analysis of the data is expected to be reported in the coming weeks.
Please note that a global phase II/III study is evaluating opaganib in a similar patient population. Top-line data from the study is expected during the first quarter of 2021. Opaganib is both anti-inflammatory and antiviral, which is believed to treat the cause and the effects of COVID-19.
Shares of RedHill have surged 31.6% in the past year compared with the industry’s increase of 2.7%.
The exploratory phase II study evaluated opaganib or placebo on top of standard of care for safety and to identify preliminary signs of activity for up to 42 days post treatment initiation. Preliminary data from the exploratory study showed no material safety differences following treatment with opaganib and placebo.
Following 14 days of treatment with opaganib, 52.6% of patients no longer required oxygen support versus 22.2% for placebo and 89.5% of patients achieved 50% reduction in supplemental oxygen compared to 66.7% for placebo. Moreover, 73.7% of patients were discharged by day 14 in the opaganib-arm compared to 55.6% for placebo. Median total oxygen requirement (AUC) over 14 days was reduced by 68% in the opaganib-arm versus 46.7% for placebo.
Notably, apart from COVID-19, opaganib is being evaluated in a phase IIa study for treating advanced cholangiocarcinoma and in a phase II study for addressing prostate cancer.
Meanwhile, RedHill is set to start a phase II/III study on its second coronavirus candidate RHB-107 for addressing patients with symptomatic COVID-19 who do not require hospitalization. The FDA cleared an investigational new drug application for the study in November.
We note that in November, the FDA granted Emergency Use Authorization (EUA) to Eli Lilly’s LLY antibody drug bamlanivimab (LY-CoV555) as a monotherapy for treating the recently-diagnosed mild-to-moderate COVID-19 illness in patients who are at high risk of progressing to severe COVID-19 or hospitalization. The FDA also granted an EUA to Lilly and Incyte’s INCY rheumatoid arthritis drug, Olumiant (baricitinib) in combination with Veklury (remdesivir) in the same month for treating hospitalized patients with COVID-19 infection. Regeneron’s REGN antibody cocktail therapy, casirivimab and imdevimab administered together (REGN-COV2) for the treatment of mild-to-moderate COVID-19 also received an EUA from the FDA in November. Several other biotechs are also developing their candidates as potential treatment of COVID-19.
Meanwhile, we note that the FDA granted EUA to coronavirus vaccines from Pfizer/BioNTech and Moderna last month. With new vaccines and treatment options available for COVID-19, a speedy recovery from the pandemic is likely in 2021.
Redhill Biopharma Ltd. Price
Redhill Biopharma Ltd. price | Redhill Biopharma Ltd. Quote
RedHill currently carries a Zacks Rank #4 (Sell).
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